Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)

Summary

Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment.

Timeline

Start

2003-11

Primary completion

2008-03

Completion

2008-06

Outcome

Missed primary endpoint

paper Mortality to 28 days after treatment, the requirement for mechanical ventilation, and the number of nonpulmonary organ failure-free days were not different between study groups. PMID 21148720 ↗

Publications

• Spragg RG, Taut FJ, Lewis JF, Schenk P, Ruppert C, Dean N, Krell K, Karabinis A, Gunther A. Recombinant surfactant protein C-based surfactant for patients with severe direct lung injury. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1055-61. doi: 10.1164/rccm.201009-1424OC. Epub 2010 Dec 10.

Drugs

Indications